Registry of Patients in Shock Treated With Vasopressin

July 11, 2024 updated by: Hospital Universitario 12 de Octubre

Prospective Multicentre Observational Study of Patients Treated With Vasopressin in Critical Care Units

Arginine-vasopressin (AVP) is a non-catecholaminergic hormone produced in the hypothalamus and released into the circulation via the neurohypophysis. It has different actions depending on the receptors through which it acts: V1 (vasoconstriction, platelet aggregation, efferent arteriole constriction of the renal glomerulus, glycogenolysis); V2 (water reabsorption, release of von Willebrand factor and factor VIII); V3 (increased cortisol and insulin).

Septic shock is the most common cause of vasoplegic shock and its management includes control of the focus, early antibiotic therapy, volume resuscitation, vasopressor therapy, support of various organ dysfunctions, as well as monitoring and follow-up.

The Surviving Sepsis Campaign (a global initiative to improve sepsis management) recommends noradrenaline as the first line of vasopressor therapy and early addition of AVP as a second line rather than further up-titration of noradrenaline when signs of hypoperfusion persist, through its action primarily on V1.

The rationale for its use in septic shock would be:

  • endogenous vasopressin deficiency present in septic shock;
  • as a catecholamine-sparing strategy, reducing the side effects of catecholamines;
  • its potential nephroprotective effect;
  • its use should be early.

The uncertainties surrounding the use of AVP in septic shock and other types of shock are many, hence the need for this registry.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The main objective is to characterise the routine clinical practice of vasopressin use in the context of shock in a multicentre observational study. By collecting clinical, analytical and echocardiographic data in a uniform manner, describing the time sequence of vasopressin and/or noradrenaline use; how long vasopressin is used; and which vasoconstrictor is more frequently withdrawn earlier: vasopressin or noradrenaline.

The secondary objectives are:

  • to assess what motivated the decision to initiate AVP: type of shock, perfusion parameters, noradrenaline dose;
  • to define the impact of initiating AVP on noradrenaline dose (whether the dose can be reduced or not), on cardiac function (whether echocardiographic data improve or worsen) and on perfusion data (whether laboratory and clinical data such as lactate, capillary refill time, mottling score or diuresis improve or worsen);
  • estimate what is the dose range of AVP used and what is the maximum dose used in routine clinical practice;
  • observe when AVP is stopped, how (abruptly or progressively);
  • describe the incidence of side effects of AVP, whether it is related to the dose of AVP and the comorbidities of the patients;
  • assess medium/long-term outcomes: 28- and 90-day mortality, ICU and hospital stay, days of vasopressor support, days of mechanical ventilation, days of renal replacement.

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
      • A Coruña, Spain
        • Not yet recruiting
        • Hospital Universitario de A Coruña
        • Contact:
          • Pablo Rama Maceiras
      • Baracaldo, Spain
        • Not yet recruiting
        • Hospital Universitario de Cruces
        • Contact:
          • Gontzal Tamayo
      • Barcelona, Spain
        • Not yet recruiting
        • Hospital del Mar
        • Contact:
          • Ramón Adalia
      • Barcelona, Spain
        • Not yet recruiting
        • Hospital Universitario Valle de Hebron
        • Contact:
          • Miriam de Nadal
      • Barcelona, Spain
        • Not yet recruiting
        • Hospital de Sant Pau
        • Contact:
          • Marta Giné Servén
      • Bilbao, Spain
        • Not yet recruiting
        • Hospital Universitario de Basurto
        • Contact:
          • Felipe Ortega Palacios
      • Donostia, Spain
        • Not yet recruiting
        • Hospital de Donostia
        • Contact:
          • Cristina García Fernández
      • Elche, Spain
        • Not yet recruiting
        • Hospital General Universitario de Elche
        • Contact:
          • Ana Pérez Carbonell
      • Gijón, Spain
        • Not yet recruiting
        • Hospital Universitario de Cabueñes
        • Contact:
          • Pablo Fernández Solano
      • León, Spain
        • Not yet recruiting
        • Complejo Asistencial Universitario de Leon
        • Contact:
          • Rafael González de Castro
      • Lugo, Spain
        • Recruiting
        • Hospital Lucus Augustus
        • Contact:
          • Lorena Mouritz
      • Madrid, Spain
      • Madrid, Spain
        • Not yet recruiting
        • Hospital General Universitario Gregorio Marañon
        • Contact:
          • Carlos Alberto Calvo García
      • Madrid, Spain
        • Not yet recruiting
        • Hospital Universitario Ramon y Cajal
        • Contact:
          • Amal Azzam
      • Madrid, Spain
        • Not yet recruiting
        • Hospital Universitario La Princesa
        • Contact:
          • Fernando Ramasco Rueda
        • Contact:
          • Jesús Nieves Alonso
      • Majadahonda, Spain
        • Not yet recruiting
        • Hospital Universitario Puerta de Hierro Majadahonda
        • Contact:
          • Reyes Iranzo
      • Ourense, Spain
        • Not yet recruiting
        • Complexo Hospitalario Universitario de Ourense
        • Contact:
          • Concepción Alonso
      • Oviedo, Spain
        • Not yet recruiting
        • Hospital Universitario Central de Asturias
        • Contact:
          • Beatriz Mancha Getino
      • Santa Cruz De Tenerife, Spain
        • Not yet recruiting
        • Hospital Universitario Nuestra Señora de Candelaria
        • Contact:
          • David Domínguez
      • Santander, Spain
        • Not yet recruiting
        • Hospital Universitario Marques de Valdecilla
        • Contact:
          • Adriana Ixquic Reyes Echeverria
      • Santiago De Compostela, Spain
        • Not yet recruiting
        • Hospital Clinico Universitario de Santiago
        • Contact:
          • Manuel Taboada
      • Tarragona, Spain
        • Not yet recruiting
        • Hospital Universitario Joan XXIII
        • Contact:
          • Diego Prendes Fernández
      • Valencia, Spain
        • Not yet recruiting
        • Hospital Clinico Universitario de Valencia
        • Contact:
          • Gerardo Aguilar
      • Valencia, Spain
        • Not yet recruiting
        • Hospital Universitari i Politecnic La Fe
        • Contact:
          • Miguel Ángel Rodenas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients in shock receiving vasopressin

Description

Inclusion Criteria:

  • Any patient over 18 years of age who is in shock and requires the administration of vasoconstrictors, to whom vasopressin is administered in the operating theatre and/or critical care unit, according to best clinical practice.

Exclusion Criteria:

  • Non-consent by patient/legal representatives

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Characterise the clinical practice of vasopressin use in the context of shock in a multicentre observational study.
Time Frame: 90 days
Describing the time sequence of vasopressin and/or noradrenaline use (what is initiated first) during shock
90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
28-day all-cause mortality
Time Frame: 28 days
Death on or before study day 28
28 days
90-day all-cause mortality
Time Frame: 90 days
Death on or before study day 90
90 days
Assess what prompted the decision to initiate AVP
Time Frame: Up to 7 days
Assess what prompted the decision to initiate AVP: type of shock (vasoplegic, hypovolemic,...), perfusion parameters (as lactate) or noradrenaline dose (microgram/kg/minute)
Up to 7 days
Define the impact of starting AVP on noradrenaline dose
Time Frame: Up to 7 days
Define the impact of starting AVP on noradrenaline dose (microgram/kg/minute)
Up to 7 days
Define the impact of starting AVP on lactate level
Time Frame: Up to 7 days
Define the impact of starting AVP on lactate level (mmol/L)
Up to 7 days
Observe when AVP is discontinued and how
Time Frame: Up to 7 days
Describe number of participants what AVP is discontinued first and how (abruptly or progressively)
Up to 7 days
Estimate the range of doses of AVP used
Time Frame: Up to 7 days
Estimate the range of doses of AVP used and the maximum dose used in routine clinical practice.
Up to 7 days
Incidence of side effects
Time Frame: Up to 7 days
Describe the incidence of side effects, whether it is related to AVP dose and patients' comorbidities.
Up to 7 days
Incidence of new renal replacement therapy
Time Frame: From onset of shock until hospital discharge, an average of 2 weeks
New receipt of renal replacement therapy after onset of shock
From onset of shock until hospital discharge, an average of 2 weeks
Vasopressor-free days to day 28
Time Frame: 28 days
Number of days between day 28 and the end of the last period of vasopressor therapy prior to day 28
28 days
Intensive care unit-free days to day 28
Time Frame: 28 days
Number of days between day 28 and the end of the last period of intensive care unit admission prior to day 28.
28 days
Hospital-free days to day 28
Time Frame: 28 days
Number of days between day 28 and the end of the last period of hospital admission prior to day 28
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitario 12 de Octubre

Investigators

  • Principal Investigator: Raquel García Álvarez, Hospital Universitario 12 de Octubre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 9, 2024

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

April 29, 2024

First Submitted That Met QC Criteria

May 17, 2024

First Posted (Actual)

May 21, 2024

Study Record Updates

Last Update Posted (Actual)

July 15, 2024

Last Update Submitted That Met QC Criteria

July 11, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VASOPRES REGISTRY

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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